Quick links to relevant pages on the TGA website
Guidance for Industry
- General requirements for advertising personalised medical devices to consumers.
- Therapeutic Goods Advertising Code: is the cornerstone of the therapeutic goods advertising regulatory framework. It sets out minimum requirements for advertising therapeutic goods to the public. Dated 1 July 2022.
TGA Quicklinks
- Global Medical Device Nomenclature (GMDN) Terms: Information to support sponsors and manufacturers.
- Australian Register of Therapeutic Goods (ARTG). Search the ARTG to find if devices you currently use are already listed.
- Glossary of Terms: Search this for definitions of terms e.g. Manufacturer, Supplier, Active medical device.
- Medical devices reforms: Personalised medical devices - Guidance on progress of regulatory refinements to personalised medical devices.
- Personalised medical devices (including 3D-printed devices) - Information and examples to help you understand the regulatory framework for personalised medical devices.
- Refinements to the Personalised Medical Device Framework - Guidance to assist sponsors and manufacturers comply with new regulations.
- Custom-made medical devices - Information for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how they are regulated by the TGA.
- Point-of-care manufacturing of medical devices - Information and guidance about the regulation of point-of-care manufacturing of medical devices.